NDA 210238, held by Akarx Inc. Avatrombopag Maleate.
As of Nov 13, 2026, NDA 210238 (Doptelet), held by Akarx Inc, was first approved by FDA on May 21, 2018, with 6 approved supplements and 0 published complete response letters.
DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment 1.
| Jul 24, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jun 26, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 21, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| DopteletEQ 20MG BASE · tablet;oral | Avatrombopag Maleate | RxReference drug |
| Jul 24, 2025 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Oct 14, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Aug 20, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Jun 26, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2019 | Supplement 2Labeling · Standard review | Approved | |
| May 21, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
